Status:
COMPLETED
A Study To Investigate The Metabolism Of GW876008 In Smokers Compared To Non-Smokers.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This study will investigate the effect of smoking on the metabolism of a single oral dose of GW876008.
Eligibility Criteria
Inclusion
- Healthy males or females.
- Normal ECG.
- Non-smokers (abstinence from smoking for at least 6 months before the start of the study) or smokers who smoke between 10 and 30 cigarettes, inclusive, per day, for at least 2 months prior to screening.
- Subjects must agree to abstain from alcohol for 24 hours prior to the start of dosing until collection of the final pharmacokinetic sample.
Exclusion
- Any serious medical disorder or condition.
- Any clinically significant laboratory abnormality.
- History of psychiatric illness.
- Any history of suicidal attempts or behavior.
- Active peptic ulcer disease.
- Positive faecal occult blood.
- Current or recent (within one year) gastrointestinal disease; a history of malabsorption, oesophageal reflux, irritable bowel syndrome; frequent (more than once a week) occurrence of heartburn; or any surgical intervention (e.g., cholecystectomy) which would be expected to influence the absorption of drugs.
- Female subjects who are currently or who are planning to become pregnant or who are lactating (from screening through at least 8 weeks after receiving study drug).
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00429728
Start Date
November 1 2006
Last Update
May 18 2009
Active Locations (1)
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1
GSK Investigational Site
Willingboro, New Jersey, United States, 08046